Package leaflet: Information for the user

LIDOCAINE OGNA 15% SPRAY

Oral mucosa spray
Lidocaine and Cetrimide
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What LIDOCAINE OGNA is and what it is used for
What you need to know before it is administered to you
How LIDOCAINE OGNA will be administered to you
Possible side effects
How to store LIDOCAINE OGNA
Contents of the pack and other information

1. What LIDOCAINA OGNA is and what it is used for

LIDOCAINA OGNA contains the active substances lidocaine and cetrimide.
Lidocaine belongs to a group of medicines called local anaesthetics, which work by blocking pain
in the area where they are applied.
Cetrimide belongs to a group of medicines known as antiseptics, which have a disinfecting action.
LIDOCAINA OGNA is indicated as a local anaesthetic and disinfectant:

to eliminate pain sensation during dental procedures (topical anaesthesia for the extraction of deciduous teeth, extraction of periodontally involved teeth, tooth preparation for crowns and bridges, removal of dental calculus);
to suppress reflexes during impression taking.

2. What you should know before being administered LIDOCAINA OGNA

You must not be given LIDOCAINA OGNA

if you are allergic to lidocaine, to other similar medicines (amide-type local anaesthetics), or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or suspect you may be pregnant;
if the patient is a child under 4 years of age.

Warnings and precautions

Talk to your doctor or nurse before you are given LIDOCAINA OGNA.
This medicine will be administered by a doctor in medical facilities equipped with the necessary equipment and medicines to manage emergencies.
Severe, sometimes fatal, reactions have rarely occurred following the use of this medicine, even in patients who previously did not experience allergic reactions when using this medicine or similar medicines.
The doctor will use this medicine with caution if you have infections in the mouth.

Other medicines and LIDOCAINA OGNA

Inform your doctor or nurse if you are currently taking, have recently taken, or might take any other medicines.
No interactions between LIDOCAINA OGNA and other medicines are known.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before being administered this medicine.
This medicine must not be administered if you are pregnant or suspect you may be pregnant.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

LIDOCAINA OGNA contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.

3. How LIDOCAINA OGNA will be administered to you

This medicine will be administered to you by a doctor.
The doctor will administer the appropriate dose of this medicine to you.
If you are given more LIDOCAINA OGNA than you should have been
This medicine will be administered to you by a doctor, therefore it is unlikely that you will be given an excessive dose. However, if you think that you have been given too much, inform your doctor or another healthcare professional immediately.
No cases of overdose have been reported.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody will experience them.
Very rare side effects affecting the nervous system, respiratory system or heart may occur as a result of an overdose or due to hypersensitivity to this medicine.
These effects are similar to those that may occur following the use of injectable local anaesthetics. Allergic-type reactions (local and general allergic reactions) are more likely to occur. Therefore, it is necessary to have immediately available trained personnel capable of managing emergency treatment should serious adverse reactions occur (neurological and cardiovascular symptoms).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LIDOCAINE OGNA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging at room temperature, away from heat sources.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What LIDOCAINA OGNA contains

The active substances are lidocaine base and cetrimide. Each 100 g of solution contains 15 g of lidocaine base and 0.10 g of cetrimide.
The other components are: propylene glycol, ethyl alcohol, saccharin, triply rectified peppermint essence.

Description of the appearance of LIDOCAINA OGNA and pack contents
Pack containing 1 bottle with metering micropump.

Marketing Authorization Holder and Manufacturer
GIOVANNI OGNA & Figli S.r.l.
Via Figini n.41 - 20835 Muggiò (MB)

Package leaflet: information for the physician

The following information is intended exclusively for doctors or healthcare professionals

Special warnings and precautions for use
It is recommended to administer the spray to limited areas of the mucosa.
Do not exceed the maximum dose of 1.3 g of solution per treatment (approximately 26 sprays), equivalent to 200 mg of lidocaine.

Dosage, method and duration of administration
Remove the cap from the bottle and attach the dedicated diffuser to the micropump. Press down fully and let the diffuser rise back up, then press down vertically another two or three times to prime the micropump.
Leave the diffuser in place.
Each spray delivers approximately 50 mg of liquid, equivalent to 7.5 mg of lidocaine.
Position the tip of the cannula about 2 cm from the area to be anesthetized, then press vertically on the diffuser. A spray of liquid will be released, covering an area of approximately 1 cm in diameter. This application may be repeated on 4 or 5 distinct and well-localized points of the mucosa during the same session.

For further information, please consult the Summary of Product Characteristics.